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Risk Assessment generated by a regulatory process
(RA)
last updated: 03 Apr 2025
Safety Assessment for EE-1 Eggplant for Direct Use as Food and Feed, or for Processing
EN
24 Aug 2020
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Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: (02) 8928-8741 to 64 local 2118, 2214, 2215, 2240,Fax:Website: http://www.da.gov.ph,
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Organization:Bureau of Plant Industry (BPI)San Andres, MalateManila, Metro Manila
1004, PhilippinesPhone: 8524-9588 local 230,Fax:Email: bpibiotech@buplant.da.gov.ph,Website: https://biotech.buplant.da.com.ph/,
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MAH-EEØØ1-6 - Bt eggplant (Bt brinjal)| Resistance to antibiotics (Kanamycin, Streptomycin), Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Selectable marker genes and reporter genes
- Consolidated Report on EE-1 Eggplant_FFP.pdf [ English ]
After reviewing the risk assessment report and the attached technical dossier, the assessors- the Scientific and Technical Review Panel (STRP), the Bureau of Plant Industry Plant Products Safety Services Division (BPI-PPSSD), the Bureau of Animal Industry (BAI), the Department of Environment and Natural Resources Biosafety Committee (DENR-BC), and the Department of Health Biosafety Committee (DOH-BC)- concurred that (1) EE-1 Eggplant is as safe for human food and animal feed as its conventional counterpart and (2) EE-1 Eggplant will not pose any significant risk to health and the environment.
The novel proteins expressed by EE-1 Eggplant— Cry1Ac and NPTII— could potentially be allergens or toxins.
The expression of the novel proteins was studied to assess the likelihood of exposure through consumption. The highest Cry1Ac expression at the fruits represent a maximum of 0.09% g protein/100 g fruit. Meanwhile, the highest NPTII expression at the fruits represent a maximum of 0.02% g protein/100 g fruit. Considering these, the likelihood of potential adverse effects through consumption is low.
The potential allergenicity and toxicity of the novel proteins Cry1Ac and NPTII were investigated via sequence similarity search at different allergens and toxins databases, digestibility assay, heat stability study, and oral gavage study. Results of all tests demonstrated that Cry1Ac and NPTII do not have allergenic nor toxic characteristics and do not have effects on survival or other clinical changes on the animal models used.
The overall risk for EE-1 Eggplant was assessed by considering the likelihood of exposure to the regulated article, its potential for being allergenic or toxic, and its substantial equivalence with its conventional counterpart. Proximal analysis have showed that there are significant differences in the crude protein, fat, fiber, and some minerals when compared to its conventional counterpart. However, these differences were within the 99% tolerance interval and are therefore not biologically relevant.
Considering that the expression of the novel proteins in EE-1 Eggplant is very minimal and are neither allergenic nor toxic, and that it is substantially equivalent to its conventional counterpart, the assessors concurred that the overall risk for EE-1 Eggplant is negligible.
Considering that the expression of the novel proteins in EE-1 Eggplant is very minimal and are neither allergenic nor toxic, and that it is substantially equivalent to its conventional counterpart, the assessors concurred that the overall risk for EE-1 Eggplant is negligible.
The assessors recommended for the issuance of a biosafety permit for direct use as food and feed, or for processing, for EE-1 Eggplant.
EN
Weedy relatives of the Solanum family have been identified, however, these are not known to exist in the Philippines. Additionally, self-pollination is generally more likely to occur over outcrossing due to the flower structure and reproductive biology of eggplant. Cross pollination of eggplants generally involves human intervention, therefore, the unintended release of the regulated article is unlikely.
EE-1 Eggplant can be detected using event-specific qPCR.
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
